FTC vs 3TC Once Daily

     Reported by Jules Levin

JM Molina et al (abstract 321) and a French research group reported on 40 treatment naÔve patients who received a once a day regimen in this pilot study of FTC+ddI+EFV. Baseline viral load was 59,000 copies/ml and CD4 count was 373. 35/40 continued on study and 5 stopped trial treatment: 2 due to adverse event, 2 stopped trial, and 1 for virologic failure. At week 64 90% of patients (ITT, m=f) had <400 copies/ml (36/40) for all patients and for 7/8 with >100,000 copies/ml at baseline. CD4s increased by 219 at week 64.

There were mild to moderate CNS side effects in 73%, diarrhea in 37% and rashes in 10%. For comparison, in poster 320 F Maggiolo et al (Italian research group) reported 48 week data on once daily regimen of 3TC 300 mg+ ddI 300mg and EFV in 75 patients. Baseline viral load was higher at 123,000 copies/ml and CD4 count was 251.

After 48 weeks 78% had <50 copies/ml. CD4s increased 210. Investigators reported results were comparable whether viral load was below or above 100,000. 14 patients interrupted treatment: 4 virologic failure, side effects (rash -2, GI discomfort 2, hallucinations 1, dizziness 1, death stroke- 1, or patient will 3).